Study of ABO2102 in KRAS-Mutated Solid Tumors

April 3, 2026 updated by: Suzhou Abogen Biosciences Co., Ltd.

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of ABO2102 in Participants With KRAS Mutant Solid Tumors

This is a multicenter, open-label Phase 1 clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, as well as preliminary anti-tumor activity of ABO2102 as monotherapy and in combination among participants with solid tumors with KRAS mutations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

101

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Principal Investigator:
          • Baiyong Shen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥18 years of age at time of informed consent.
  2. Have a genetically tested report confirmed by the investigator or complete genetic testing during the screening period, with evidence of harboring any of required KRAS mutations
  3. Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors.
  4. According to RECIST v1.1, at least one measurable lesion is required.
  5. No severe hematological, hepatic, renal or coagulation dysfunction; laboratory test results during the screening period must meet the respective criteria specified in the study protocol.
  6. Females of childbearing potential and males who are involved in heterosexual activity must agree to practice highly effective contraception.

Exclusion Criteria:

  1. Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or carcinoma in situ of the breast or cervix.
  2. Has known symptomatic central nervous system (CNS) metastases, or CNS metastases requiring local CNS-directed therapy .
  3. Received KRAS cancer vaccine before.
  4. History of severe (≥ Grade 3) hypersensitivity reactions to immunotherapy.
  5. History of allogeneic organ transplantation or graft-versus-host disease (GVHD).
  6. Any active infection (except for hepatitis virus infection) requires systemic treatment.
  7. Absence of spleen
  8. Known psychiatric disorder or drug abuse that may interfere with the trial requirements
  9. Participant is pregnant or breastfeeding or expecting to conceive within the projected duration of the study.
  10. Other conditions that Investigators consider inappropriate for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABO2102 Injection
Monotherapy
Drug: ABO2102 Injection
mRNA encoding mutant KRAS neoantigens, administrated intramuscularly
Experimental: ABO2102 Injection and Sintilimab Injection
ABO2102 Injection in combination with Sintilimab Injection
Drug: ABO2102 Injection
mRNA encoding mutant KRAS neoantigens, administrated intramuscularly
Drug: Sintilimab injection
Anti-PD-1 antibody, administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part I: dose-limiting toxicities (DLT) with ABO2102 as monotherapy and in combination with Sintilimab
Time Frame: 28 days after the first dose of study treatment
28 days after the first dose of study treatment
Part I: Incidence and severity of adverse events
Time Frame: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy
from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy
Part II: ORR evaluated by investigators according to RECIST v1.1 criteria
Time Frame: from the first dose of study treatment to up to 3 years
from the first dose of study treatment to up to 3 years
Part II: PFS evaluated by investigators according to RECIST v1.1 criteria
Time Frame: from the first dose of study treatment to up to 3 years
from the first dose of study treatment to up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Abogen Biosciences Co., Ltd.

Collaborators

Abogen Biosciences (Shanghai) Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABO2102-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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